the ifix system - zimmerbiomet.com · 9 | ifix system surgical technique insert ifix guide wire...

The iFix® System

Surgical Technique

Table of Contents

Introduction .............................................................................................................. 1

Graft Preparation ...................................................................................................... 2

Femoral Tunnel Localization ..................................................................................... 3

Placement of Nitinol Guide Wire .............................................................................. 5

Femoral Tunnel Length ............................................................................................. 6

Prepare the Relay Stitch ........................................................................................... 8

Implant Preparation................................................................................................ 10

Indications and Contraindications for Use ............................................................. 12

1 | iFix System Surgical Technique

IntroductionThe iFix System does not change the surgical technique that physicians are currently following when performing a bone-patellar tendon-bone ACL reconstruction. This surgical guide is to review the standard technique with a few points related specifically to the iFix System.


Figure 1 Figure 2

Graft PreparationHarvest the middle third of the Patellar Tendon from the patient’s knee (Figure 1).

Create small drill holes using a 2 mm drill, on shaped bone blocks, for insertion of sutures that are later used to pass graft up through the tunnels for final placement (Figure 2).

Size the patellar graft, using the Zimmer Biomet Tendon Sizing Block, so that the bundle passes through the sizing block with a snug/tight fit.


Insert the bullet to the lateral thigh to make an indentation in the skin. Pull back on the bullet to make a small skin incision, and then advance the bullet down to the lateral cortex (Figure 4). Note the length of the femoral tunnel on the bullet and guide system to make certain there is adequate length before proceeding with the SwitchCut reamer (Figure 4a).

Note: When placing the bullet into the SwitchCut femoral guide, orient the teeth on the bullet toward the ratchet mechanism on the SwitchCut guide body.

Femoral Tunnel Preparation Insert the SwitchCut™ Side Specific Guide & BulletInsert the side specific (Right or Left) SwitchCut Femoral guide into the joint space, keeping in mind that the crescent shape tip of the femoral guide has an outer diameter of 12 mm and an inner diameter of 8 mm (Figure 3).

Figure 3 Figure 4

Figure 4aFigure 3a


Create a Femoral Tunnel with the SwitchCut ReamerReam in a clockwise forward direction through the lateral cortex into the joint space (Figures 5 & 5a).

Once the SwitchCut tip has penetrated the entrance of the joint, as shown in Figure 3a, then rotate the bullet 90 .̊ Remove the SwitchCut guide from the joint space, leaving the bullet in place (Figure 6).

Figure 5 Figure 6

Figure 5a


Create a Femoral Tunnel with the SwitchCut Reamer (cont.)Use a mallet to gently tap the bullet into the lateral cortex bone until it bottoms out on the positive stop (Figure 7).

Advance the tip of the SwitchCut reamer to the bold black line. This will zero out the SwitchCut reamer (Figure 8). Once the black etched line is aligned with the intra-articular entrance, slide the O-ring to the back of the bullet (Figure 8a).

Figure 7

Figure 8

Figure 8a


Ream the Femoral SocketReam in a counterclockwise (reverse) direction to drill the femoral socket. The arm on the SwitchCut reamer will automatically deploy as soon as it contacts bone (Figure 9). Ensure the drill is running at a maximum counterclockwise speed and maintain a constant and slow retro reaming motion. While retro reaming, count the etch marks on the SwitchCut reamer to determine the femoral socket depth, knowing that each etch line represents 5 mm (Figure 9a).

If desired, retro-ream until the SwitchCut reamer bottoms out on the bullet tip, which will leave a 7 mm bone bridge. Do NOT continue to ream once the reamer makes contact with the bullet, as this may cause the tip of the reamer to break. Then disconnect the Jacobs® Chuck from the SwitchCut reamer.

Figure 9 Figure 9a


Shuttle the Nitinol Loop PasserRemove the blue handled k-wire by twisting counterclockwise (reverse) (Figure 10) and pass the Nitinol loop passer, kite side first, down the SwitchCut reamer as shown (Figure 10a).

Figure 10 Figure 10a


Pass the Nitinol loop passer until it is seen in the joint space. Use a suture retriever to pull the loop passer out of the joint space (Figures 11 and 11a).

Note: Once the loop passer is out of the joint space, gently remove the SwitchCut reamer by hand with a clockwise twisting motion. When the SwitchCut reamer has been withdrawn, bring both ends of the Nitinol wire together and clamp them using a hemostat.

Figure 11 Figure 11a

Tibial Tunnel PreparationPrepare the tibial tunnel by using a tibial guide. Place the tunnel in the anatomic position on the tibia. Drill a 2.4 mm guide wire through the guide. Ream over the guide wire with the corresponding reamer to the previously determined graft size.

After creating the tibial tunnel, retrieve the Nitinol loop passer from the joint space and pull the Nitinol loop passer through the tibial tunnel for passing of the implant (Figure 12).

Figure 12


Insert iFix Guide Wire through iFix Driver and lock guide wire by turning the dial on the driver clockwise until tight. Next, load the iFix Interference Screw onto the driver. Some surgeons may prefer to insert the guide wire first, remove driver and then load screw for insertion.

Insert iFix Guide Wire opposite the tendinous portion of the graft in the anteromedial portion of the tunnel for the desired placement of the screw.

Once Guide Wire is in place, turn dial on driver counter-clockwise to loosen grip on Guide Wire and prepare for screw insertion (Figure 15).

Implant PreparationPull upward on the SwitchCut nitinol wire to pass the relay stitches of the BTB graft (Figure 13 & 14).

Verify graft position within the tunnel. Typically the cortical side of the bone plug is placed in the posterolateral aspect of the femoral tunnel, placing the tendinous portion of the graft at the posterolateral portion of the aperture.

Figure 13 Figure 15

Figure 14


Insert iFix Interference Screw using iFix Driver into the desired location of the femoral tunnel. The triangle marking on distal end of iFix screw indicates the position of the angled tip for optimal positioning during screw insertion (Figure 16).

No tapping or tunnel notching is required prior to insertion of the iFix Interference Screw.

Insert screw until the head is flush with the distal end of the bone block (Figure 17).

Figure 16

Figure 17

Once femoral fixation is complete, the tibial graft is then fixed in a similar fashion. Positioning of the graft, in relation to the surfaces for healing versus fixation is surgeon preference.

Insert iFix Interference Screw until the head is flush with the distal end of the graft bone block (Figure 18).

Figure 18

Figure 19


iFix Interference Screw

Part Number Size

CM-1720CM-1725CM-1820CM-1825CM-1830CM-1920CM-1925CM-1930 CM-1025 CM-1030 CM-1130CM-1230

7 mm x 20 mm 7 mm x 25 mm 8 mm x 20 mm 8 mm x 25 mm 8 mm x 30 mm 9 mm x 20 mm 9 mm x 25 mm 9 mm x 30 mm 10 mm x 25 mm 10 mm x 30 mm 11 mm x 30 mm 12 mm x 30 mm

iFix Driver

Part Number Size

CM-1245 CM-1345

2.45 mm 3.45 mm

Switchcut

Part Number Description Size

110026884 Nitinol Loop Passer –

110026898 SwitchCut Guide Bullet 4.5 mm ID

110026902 SwitchCut Guide Bullet 6.0 mm ID

110026899 SwitchCut Universal Guide Body –

110026900 SwitchCut Femoral Guide Arm Right –

110026901 SwitchCut Femoral Guide Arm Left –

110026903 SwitchCut Tibial Guide Arm –

110027674110027675110027676110027677110027678110027679110027680110027681110027682110027683110027684

SwitchCut Reamer w/ Nitinol Passers 4.5 x 6.0 mm4.5 x 6.5 mm4.5 x 7.0 mm4.5 x 7.5 mm4.5 x 8.0 mm4.5 x 8.5 mm4.5 x 9.0 mm4.5 x 9.5 mm4.5 x 10.0 mm4.5 x 10.5 mm4.5 x 11.0 mm

110026911 SwitchCut Caddy

900334 MaxBraid™ Blue/White Cobraid Suture with Tapered HC-5 Needle, 12 Pack

#2

Ordering Information


INDICATIONSThe iFix® Interference Screw is intended for use with BPTB grafts to provide fixation during arthroscopic or open ACL reconstruction procedures.

CONTRAINDICATIONS1. Surgical procedures other than those listed in the

INDICATIONS section.

2. Presence of infection.

3. Patient conditions including insufficient quantity or quality of bone or soft tissue.

4. Insufficient blood supply or previous infections which may hinder the healing process.

5. Foreign body sensitivity. If material sensitivity is suspected, testing should be completed prior to device implantation.

6. The use of this device may not be suitable for patients with immature bone. The physician should carefully assess the status of the physes of the distal femur and proximal tibia before performing ACL reconstruction surgery on patients who are skeletally immature.

7. Conditions which may limit the patient’s ability or willingness to follow postoperative care instructions.

Jacobs® is a trademark of Apex Brands, Inc.

All content herein is protected by copyright, trademarks and other intellectual property rights, as applicable, owned by or licensed to Zimmer Biomet or its affiliates unless otherwise indicated, and must not be redistributed, duplicated or disclosed, in whole or in part, without the express written consent of Zimmer Biomet.

This material is intended for health care professionals. Distribution to any other recipient is prohibited.

For product information, including indications, contraindications, warnings, precautions, potential adverse effects and patient counseling information, see the package insert and www.zimmerbiomet.com.

Check for country product clearances and reference product specific instructions for use.

Zimmer Biomet does not practice medicine. This technique was developed in conjunction with a health care professional. This document is intended for surgeons and is not intended for laypersons. Each surgeon should exercise his or her own independent judgment in the diagnosis and treatment of an individual patient, and this information does not purport to replace the comprehensive training surgeons have received. As with all surgical procedures, the technique used in each case will depend on the surgeon’s medical judgment as the best treatment for each patient. Results will vary based on health, weight, activity and other variables. Not all patients are candidates for this product and/or procedure. Caution: Federal (USA) law restricts this device to sale by or on the order of a surgeon. Rx only.

© 2019 Zimmer Biomet.

2029.1-GLBL-en-REV0419

the ifix system - zimmerbiomet.com · 9 | ifix system surgical technique insert ifix guide wire...

Documents